GUEST COLUMNISTS

• Building CGT Manufacturing Capacity For The Next Commercial Era

  Recent investments — mostly by CDMOs — are expanding manufacturing capacity to support the growing cell and gene therapy pipeline. We also discuss associated trends and impacts.

• Top 5 Challenges In Antibody-Oligonucleotide Manufacturing

  AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.

• Managing The Presence Of Visible Particulates In Cell Therapies

  Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls. 

• Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

  Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

  In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

• Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines

  Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools

  Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.